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This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.
This is a randomised-intervention, parallel, multicentre study which will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with silodosin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard silodosin treatment | Active Comparator | Peroral treatment with silodosin at a dose of 8 mg daily |
|
| Standard silodosin treatment with PFMT | Experimental | Peroral treatment with silodosin at a dose of 8 mg daily Intervention: Behavioural: Pelvic floor muscle training (PFMT) with suppressive urgency technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle training (PFMT) with suppressive urgency technique | Behavioral | Pelvic floor muscle training with suppressive urgency technique:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary. | The investigators will compare change in the number of voidings and the intensity of urgencies during 24 hours in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. | over 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lower urinary tract symptoms. | To examine changes in the score of lower urinary tract symptoms (LUTS) by the International Prostate Symptom Score (IPSS) in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. 0 = minimum score, 35 = maximum score. | over 12 weeks of treatment |
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Inclusion criteria:
• willing to provide written informed consent
Exclusion criteria:
Men
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| Name | Affiliation | Role |
|---|---|---|
| Jan Svihra, Prof,MD,PhD | Department of Urology, Jessenius Faculty of Medicine, Comenius University Bratislava Slovak Republic | Study Director |
| Magdalena Hagovska, Assoc.pr.PhD | Faculty of Medicine, PJ Safarik University, Kosice, Slovak Republic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Svihra | Martin | 03601 | Slovakia |
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Parallel Assignment
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|
| Change in incontinence quality of life . |
To examine change in incontinence quality of life by Overactive Bladder Questionnaire (OAB - q) in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. 0 = the worst to 100 = the best quality of life. |
| over 12 weeks of treatment |
| Change in patient global impression of improvement | To examine changes in patient global impression of improvement in the combined silodosin and pelvic floor muscle training to silodosin treatment alone . 1 = much better. 7 = definitely worse. | over 12 weeks of treatment |
| Incidence of adverse events . | To examine the incidence of adverse events in the combined silodosin and pelvic floor muscle training to silodosin treatment alone. | over 12 weeks of treatment |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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